Mechanical VentilationMOVCARENCT07188350
Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)
A study testing Conventional Physical Therapy and Neuromuscular Electrical Stimulation (NMES) in people with Mechanical Ventilation and Critical Illness, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Illness, Intensive Care Unit Patients
- What is being tested?
- Conventional Physical Therapy and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Sep 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible if they are 18 years or older, are under invasive mechanical ventilation (IMV), and are expected to require IMV for more than 48 hours.
Who cannot join
- Body mass index (BMI) greater than or equal to 35 kg/m²;
- Length of ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation (IMV) before enrollment;
- Known intracranial process (e.g., stroke, intracranial hypertension);
- Neuromuscular disease (e.g., Guillain-Barré syndrome, myasthenia gravis) at ICU admission;
- Inability to speak Portuguese or pre-existing cognitive impairment prior to ICU admission;
- Any condition that prevents neuromuscular electrical stimulation (NMES) treatment or assessment of the primary outcome in both legs (e.g., skin lesions, fractures, or amputation);
Show all 12Show fewer
- inability to transfer from bed to chair with or without assistance prior to hospital admission;
- Cardiac arrest as the cause of ICU admission or cardiac arrest before screening;
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) treated for less than 48 hours;
- Pregnant patients;
- Known or suspected malignancy in the legs;
- Any care limitation including a do-not-resuscitate order.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-902
Larissa C Brandão da Cunha, MS, 5551996285425, larissabran@yahoo.com.br
Cassiano Teixeira, Doctor, 5551999687062, cassiano.rush@gmail.com
About this study
Official title: Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial
This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Participants will be randomly assigned to receive either conventional physical therapy or the same therapy plus NMES applied to the lower limbs. The protocol includes muscle-specific stimulation parameters and safety criteria to postpone sessions in cases of clinical instability. The primary goal is to assess whether NMES improves muscle function and recovery in critically ill patients.
Read the detailed description
This randomized clinical trial will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients undergoing invasive mechanical ventilation. Participants will be randomly assigned to two groups: a control group receiving conventional physical therapy alone and an intervention group receiving conventional physical therapy combined with NMES.
The control group will receive individualized conventional physical therapy, adjusted daily based on each patient's physiological status and following protocols supported by current literature. Interventions may include progressive mobility, such as bed exercises, rolling, sitting at the edge of the bed, standing, chair transfers, and ambulation, as well as respiratory physiotherapy techniques including bronchial hygiene, pulmonary re-expansion, and management of mechanical ventilation. Sessions will last approximately 20 minutes and continue throughout hospitalization, except in cases of clinical contraindications or refusal by the patient/family.
The NMES group will receive the same conventional physical therapy described above, plus NMES applied once or twice daily to both lower limbs for up to 14 consecutive days or until hospital discharge, whichever comes first.
Rectangular electrodes (90 × 50 mm) will be placed bilaterally on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. If hair interferes with electrode adhesion, the area will be shaved.
NMES will be delivered using the ReCARE® device (Visuri, MG, Brazil) with the following parameters:
Frequency: 60 Hz
Pulse duration: 500 µs
Intensity: adjusted to produce visible muscle contractions during the first two days and, from day three onward, contractions sufficient to generate movement against gravity.
Contraction (on) and relaxation (off) times and the number of contractions will be progressively adjusted according to the 14-day protocol:
Days 1-2: On = 9s, Off = 22s, 30 contractions, 1x/day
Days 3-6: On = 9s, Off = 20s, 40 contractions, 1x/day
Days 7-9: On = 9s, Off = 18s, 50 contractions, 1x/day
Days 10-14: On = 9s, Off = 15s, 60 contractions, 1x/day
NMES sessions will be postponed if the participant exhibits any of the following clinical findings within three hours prior to the session:
Acidosis (arterial pH < 7.25 or venous pH < 7.20)
Hypotension or hypertension (mean arterial pressure < 60 mmHg or > 140 mmHg)
Use of a single vasopressor at >50% of the ICU maximum dose (e.g., dopamine >12.5 µg/kg/min, phenylephrine >2 µg/kg/min, vasopressin ≥0.02 U/min, norepinephrine >1 µg/kg/min)
Use of two vasopressors at ≥40% of the ICU maximum dose
New diagnosis of pulmonary embolism or deep vein thrombosis without anticoagulation for more than 48 hours
Other signs of physiological instability, including temperature <34°C or >41°C, lactate >3.0 mmol/L, creatine kinase >400 U/L, platelet count <20,000/mm³, or suspected muscle inflammation (e.g., rhabdomyolysis, myositis, neuroleptic malignant syndrome, or serotonin syndrome).
This study aims to determine whether NMES, as an early adjunct therapy, can improve recovery and clinical outcomes in critically ill mechanically ventilated patients when combined with conventional physical therapy.
Protocol Amendment and Rationale The study protocol was amended following study initiation due to operational and feasibility constraints identified during the early recruitment phase (from the second enrolled participant onwards), particularly related to limited availability of research personnel required for intervention delivery as originally designed.
Amendments implemented:
- Study duration and intervention schedule The intervention duration was reduced from 20 to 14 days. In addition, the original protocol of two daily sessions during the initial phase was modified to a single daily session throughout the intervention period. Stimulation parameters were also adjusted, including optimization of on/off time and number of contractions, resulting in a shorter and more feasible protocol while maintaining the intended neuromuscular stimulation dose.
- Eligibility criteria modification The exclusion criterion related to baseline mobility was refined. The original criterion excluding patients unable to independently leave the bed was modified to exclude patients who were either unable to leave the bed independently or had pre-existing dependence for mobility prior to hospital admission, in order to improve baseline functional homogeneity and recruitment feasibility.
- Blinding procedures Outcome assessor blinding was removed. Although initially planned, blinding was not feasible due to limited research personnel and logistical constraints associated with intervention delivery.
Rationale:
These amendments were introduced to ensure study feasibility under resource and staffing constraints while maintaining protocol integrity and alignment with the physiological objectives of the intervention.
Importantly, these changes were implemented early in the recruitment process and reflect an adaptation toward a more feasible and clinically applicable protocol.
Impact:
These modifications do not affect the study objectives, primary or secondary outcomes, or participant safety. The intervention remains within established safety parameters for neuromuscular electrical stimulation, and no additional risk to participants has been introduced.
- Conditions
- Mechanical Ventilation, Critical Illness, Intensive Care Unit Patients, Muscle Weakness Condition, Neuromuscular Electrical Stimulation (NMES)
- Being tested
- Conventional Physical Therapy, Neuromuscular Electrical Stimulation (NMES)
- Keywords
- Neuromuscular Electrical Stimulation, Physiotherapy, Mechanical Ventilation, Muscle Strength, Randomized Controlled Trial, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyOther
Individualized physical therapy including progressive mobility (e.g., bed exercises, sitting on the edge of the bed, standing, transfers, and ambulation) and respiratory therapy tailored to the patient's clinical condition. Delivered daily by trained professionals.
Neuromuscular Electrical Stimulation (NMES)Device
NMES will be applied to both lower limbs once or twice daily for 20 consecutive days. Electrodes will be positioned on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. The stimulation protocol includes progressive parameters to induce visible and effective muscle contractions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy | Active comparator | Participants in this group will receive individualized conventional physical therapy, including progressive mobility exercises, in-bed activities (e.g., rolling, sitting at the edge of the bed), standing, transferring to a chair, walking, and respiratory therapy as clinically indicated. Treatments will be adjusted daily based on each patient's physiological status. Receives: Other: Conventional Physical Therapy |
| Conventional Physical Therapy + Neuromuscular Electrical Stimulation | Experimental | Participants in this group will receive the same conventional physical therapy as the control group, plus neuromuscular electrical stimulation (NMES) applied to both lower limbs once or twice daily for 14 consecutive days. NMES will be administered to the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles using specific parameters to produce effective muscle contractions, following a progressive stimulation protocol throughout the intervention period. Receives: Other: Conventional Physical Therapy; Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
Measured: Within 24 hours after ICU discharge
Secondary outcomes (24)
Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation
The thickness of the rectus femoris muscle will be measured in millimeters using ultrasound imaging performed by trained professionals, in order to assess muscle morphology.
Measured: within 24 hours after enrollment
Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle of the rectus femoris will be measured in degrees to assess muscle architecture.
Measured: within 24 hours after enrollment
Rectus femoris pennation angle measured by ultrasound at sedation awakening
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle architecture at sedation awakening.
Unit of Measure: degrees (°)
Measured: Within 24 hours after awakening from sedation in the ICU
Rectus femoris muscle thickness measured by ultrasound at sedation awakening
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured. Assessments will be performed when sedation is reduced or stopped to the point that the patient can respond to at least three motor commands (e.g., blink eyes, look at the examiner, stick out tongue, shake head, or raise eyebrows), in order to assess muscle morphology at sedation awakening.
Unit of Measure: millimeters (mm)
Measured: Within 24 hours after awakening from sedation in the ICU
Rectus femoris pennation angle measured by ultrasound at ICU discharge
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured to assess muscle architecture. Each value will be recorded individually at ICU discharge.
Unit of Measure: degrees (°)
Measured: Within 24 hours after ICU discharge
Rectus femoris muscle thickness measured by ultrasound at ICU discharge
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured to assess muscle morphology. Each value will be recorded individually at ICU discharge.
Unit of Measure: millimeters (mm)
Measured: Within 24 hours after ICU discharge
Rectus femoris pennation angle measured by ultrasound at hospital discharge
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. The pennation angle (in degrees) will be measured to assess muscle architecture. Assessments will be performed at hospital discharge.
Unit of Measure: degrees (°)
Measured: From 48 hours to 0 hours before hospital discharge
Rectus femoris muscle thickness measured by ultrasound at hospital discharge
The quadriceps muscle (specifically the rectus femoris) will be evaluated using ultrasound imaging by trained professionals. Muscle thickness (in millimeters) will be measured to assess muscle morphology. Assessments will be performed at hospital discharge.
Unit of Measure: millimeters (mm)
Measured: From 48 hours to 0 hours before hospital discharge
Muscle strength assessed by the Medical Research Council (MRC) sum score at awakening from sedation
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) sum score, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. Assessments will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle strength at sedation awakening.
Measured: Within 24 hours after awakening from sedation in the ICU
Muscle strength assessed by the Medical Research Council (MRC) sum score at hospital discharge
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. Assessments will be performed at three time points: awakening from sedation, ICU discharge, and hospital discharge. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
Measured: From 48 hours to 0 hours before hospital discharge
Handgrip strength measured at awakening from sedation in the ICU
Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy. Assessments will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle.
Measured: Within 24 hours after awakening from sedation in the ICU
Handgrip strength measured at ICU discharge
Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy.
Measured: Within 24 hours after ICU discharge
Handgrip strength measured at hospital discharge
Handgrip strength will be assessed using a handheld hydraulic dynamometer, which measures the maximum force the participant can apply by squeezing the device with their hand. The participant will remain seated with their feet flat on the floor and the arm positioned in a standardized manner to ensure measurement accuracy.
Measured: From 48 hours to 0 hours before hospital discharge
Isometric Knee Extension Strength Assessed at Awakening From Sedation in the ICU
Isometric knee extension strength will be assessed using a portable dynamometer. Participants will be seated with the knee at a 60-degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force generated by the quadriceps while the joint remains still. Assessments will be conducted by trained professionals using standardized procedures. Measurements will be performed when sedation is reduced or stopped so that the patient can respond to at least three motor commands (e.g., blink eyes, look at examiner, stick out tongue, shake head, raise eyebrows) to assess muscle strength at sedation awakening.
Measured: Within 24 hours after awakening from sedation in the ICU
Isometric Knee Extension Strength Assessed at ICU Discharge
Isometric knee extension strength will be assessed using a portable dynamometer. The participant will be seated with the knee positioned at a 60 degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force the quadriceps can generate while the joint remains still. The assessment will be conducted by trained professionals using standardized procedures.
Measured: Within 24 hours after ICU discharge
Isometric Knee Extension Strength Assessed at Hospital Discharge
Isometric knee extension strength will be assessed using a portable dynamometer. The participant will be seated with the knee positioned at a 60 degree angle of flexion and instructed to push the leg forward against the device without moving the joint. This test measures the force the quadriceps can generate while the joint remains still. The assessment will be conducted by trained professionals using standardized procedures.
Measured: From 48 hours to 0 hours before hospital discharge
Functional capacity assessed by the Six-Minute Walk Test (6MWT)
The six-minute walk test (6MWT) will be conducted by trained physiotherapists to assess functional exercise capacity. The total distance walked in six minutes will be recorded following standardized procedures.
Measured: From 48 hours to 0 hours before hospital discharge
Barthel Index Assessed at Study Enrollment
Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). At study enrollment, the questionnaire will be answered by the patient's family member or primary caregiver to provide a baseline assessment of the patient's functional status prior to ICU admission. The Barthel Index assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Measured: At baseline (study enrollment)
Barthel Index Assessed at Hospital Discharge
Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). The questionnaire assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Measured: From 48 hours to 0 hours before hospital discharge
Barthel Index Assessed at 6 Months Post Hospital Discharge
Functional independence will be evaluated using the Barthel Index, a questionnaire that measures a patient's ability to perform activities of daily living (ADLs). At 6 months post hospital discharge, the patient will be contacted by telephone to complete the questionnaire. The Barthel Index assesses independence in areas such as personal care, mobility, locomotion, and elimination. Each activity is scored based on the patient's level of independence, assistance needed, or dependence. Scores range from 0 to 100 in increments of five, with higher scores indicating greater functional independence.
Measured: 6 months after hospital discharge
Duration of invasive mechanical ventilation (IMV)
The duration of invasive mechanical ventilation (IMV) will be measured from the initiation of IMV until the day of extubation. This duration will be verified and confirmed through review of the patient's medical records.
Measured: Within 24 hours after ICU discharge
Ventilator-free days
The number of days during which the patient was alive and free from invasive mechanical ventilation (IMV) during the ICU stay. This information will be collected from the patient's medical records at hospital discharge.
Measured: Within 24 hours after ICU discharge
Length of stay in ICU and hospital
The total number of days the patient remains admitted in the Intensive Care Unit (ICU) and the hospital during their treatment period. This includes the time from ICU admission until discharge from the hospital. This information will be collected from the patient's medical records at hospital discharge.
Measured: Within 24 hours after hospital discharge
Mortality
The number of deaths occurring among study participants during the hospital stay and within six months after hospital discharge.
Measured: From hospital admission until death or up to 180 days (6 months) after hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start4 Sep 2025
- Primary completion5 Sep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups in a parallel design: the control group receiving conventional physical therapy, and the intervention group receiving conventional physical therapy plus neuromuscular electrical stimulation. Both groups will be treated simultaneously during the study period.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Principal investigator, Cassiano Teixeira, Hospital Moinhos de Vento
- Investigators
- Cassiano TEIXEIRA, PhD, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188350
- Sponsor's protocol ID
- MOVCARE2025-LB
- Acronym
- MOVCARE
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study, including the analyzable dataset, will be shared with qualified researchers for academic purposes.
Publications
Hogrel JY, Benveniste O, Bachasson D. Routine monitoring of isometric knee extension strength in patients with muscle impairments using a new portable device: cross-validation against a standard isokinetic dynamometer. Physiol Meas. 2020 Feb 5;41(1):015003. doi: 10.1088/1361-6579/ab6b49.
PubMed 31935703Britto RR, Probst VS, de Andrade AF, Samora GA, Hernandes NA, Marinho PE, Karsten M, Pitta F, Parreira VF. Reference equations for the six-minute walk distance based on a Brazilian multicenter study. Braz J Phys Ther. 2013 Nov-Dec;17(6):556-63. doi: 10.1590/S1413-35552012005000122. Epub 2013 Nov 14.
PubMed 24271092Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
PubMed 21570036Stefanou C, Karatzanos E, Mitsiou G, Psarra K, Angelopoulos E, Dimopoulos S, Gerovasili V, Boviatsis E, Routsi C, Nanas S. Neuromuscular electrical stimulation acutely mobilizes endothelial progenitor cells in critically ill patients with sepsis. Ann Intensive Care. 2016 Dec;6(1):21. doi: 10.1186/s13613-016-0123-y. Epub 2016 Mar 11.
PubMed 26969168Silva PE, Babault N, Mazullo JB, de Oliveira TP, Lemos BL, Carvalho VO, Durigan JLQ. Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study. J Crit Care. 2017 Feb;37:141-148. doi: 10.1016/j.jcrc.2016.09.012. Epub 2016 Sep 22.
PubMed 27732921Sachetti A, Carpes MF, Dias AS, Sbruzzi G. Safety of neuromuscular electrical stimulation among critically ill patients: systematic review. Rev Bras Ter Intensiva. 2018 Apr-Jun;30(2):219-225. doi: 10.5935/0103-507X.20180036.
PubMed 29995088Padte S, Samala Venkata V, Mehta P, Tawfeeq S, Kashyap R, Surani S. 21st century critical care medicine: An overview. World J Crit Care Med. 2024 Mar 9;13(1):90176. doi: 10.5492/wjccm.v13.i1.90176. eCollection 2024 Mar 9.
PubMed 38633477Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688Rodriguez PO, Setten M, Maskin LP, Bonelli I, Vidomlansky SR, Attie S, Frosiani SL, Kozima S, Valentini R. Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation. J Crit Care. 2012 Jun;27(3):319.e1-8. doi: 10.1016/j.jcrc.2011.04.010. Epub 2011 Jun 28.
PubMed 21715139Nosaka K, Aldayel A, Jubeau M, Chen TC. Muscle damage induced by electrical stimulation. Eur J Appl Physiol. 2011 Oct;111(10):2427-37. doi: 10.1007/s00421-011-2086-x. Epub 2011 Aug 3.
PubMed 21811767Nakanishi N, Oto J, Tsutsumi R, Yamamoto T, Ueno Y, Nakataki E, Itagaki T, Sakaue H, Nishimura M. Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial. Crit Care Med. 2020 Nov;48(11):e997-e1003. doi: 10.1097/CCM.0000000000004522.
PubMed 32897665Maffiuletti NA. Physiological and methodological considerations for the use of neuromuscular electrical stimulation. Eur J Appl Physiol. 2010 Sep;110(2):223-34. doi: 10.1007/s00421-010-1502-y. Epub 2010 May 15.
PubMed 20473619Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Sommers J, Engelbert RH, Dettling-Ihnenfeldt D, Gosselink R, Spronk PE, Nollet F, van der Schaaf M. Physiotherapy in the intensive care unit: an evidence-based, expert driven, practical statement and rehabilitation recommendations. Clin Rehabil. 2015 Nov;29(11):1051-63. doi: 10.1177/0269215514567156. Epub 2015 Feb 13.
PubMed 25681407Vanhorebeek I, Latronico N, Van den Berghe G. ICU-acquired weakness. Intensive Care Med. 2020 Apr;46(4):637-653. doi: 10.1007/s00134-020-05944-4. Epub 2020 Feb 19.
PubMed 32076765
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07188350
- Acronym / sponsor ID
- MOVCARE / MOVCARE2025-LB
- Conditions
- Mechanical Ventilation, Critical Illness, Intensive Care Unit Patients, Muscle Weakness Condition, Neuromuscular Electrical Stimulation (NMES)
- Keywords
- Neuromuscular Electrical Stimulation, Physiotherapy, Mechanical Ventilation, Muscle Strength, Randomized Controlled Trial, Critical Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Participants will be randomly assigned to receive either conventional physical therapy or the same therapy plus NMES applied to the lower limbs. The protocol includes muscle-specific stimulation parameters and safety criteria to postpone sessions in cases of clinical instability. The primary goal is to assess whether NMES improves muscle function and recovery in critically ill patients.
Detailed description
This randomized clinical trial will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients undergoing invasive mechanical ventilation. Participants will be randomly assigned to two groups: a control group receiving conventional physical therapy alone and an intervention group receiving conventional physical therapy combined with NMES.
The control group will receive individualized conventional physical therapy, adjusted daily based on each patient's physiological status and following protocols supported by current literature. Interventions may include progressive mobility, such as bed exercises, rolling, sitting at the edge of the bed, standing, chair transfers, and ambulation, as well as respiratory physiotherapy techniques including bronchial hygiene, pulmonary re-expansion, and management of mechanical ventilation. Sessions will last approximately 20 minutes and continue throughout hospitalization, except in cases of clinical contraindications or refusal by the patient/family.
The NMES group will receive the same conventional physical therapy described above, plus NMES applied once or twice daily to both lower limbs for up to 14 consecutive days or until hospital discharge, whichever comes first.
Rectangular electrodes (90 × 50 mm) will be placed bilaterally on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. If hair interferes with electrode adhesion, the area will be shaved.
NMES will be delivered using the ReCARE® device (Visuri, MG, Brazil) with the following parameters:
Frequency: 60 Hz
Pulse duration: 500 µs
Intensity: adjusted to produce visible muscle contractions during the first two days and, from day three onward, contractions sufficient to generate movement against gravity.
Contraction (on) and relaxation (off) times and the number of contractions will be progressively adjusted according to the 14-day protocol:
Days 1-2: On = 9s, Off = 22s, 30 contractions, 1x/day
Days 3-6: On = 9s, Off = 20s, 40 contractions, 1x/day
Days 7-9: On = 9s, Off = 18s, 50 contractions, 1x/day
Days 10-14: On = 9s, Off = 15s, 60 contractions, 1x/day
NMES sessions will be postponed if the participant exhibits any of the following clinical findings within three hours prior to the session:
Acidosis (arterial pH < 7.25 or venous pH < 7.20)
Hypotension or hypertension (mean arterial pressure < 60 mmHg or > 140 mmHg)
Use of a single vasopressor at >50% of the ICU maximum dose (e.g., dopamine >12.5 µg/kg/min, phenylephrine >2 µg/kg/min, vasopressin ≥0.02 U/min, norepinephrine >1 µg/kg/min)
Use of two vasopressors at ≥40% of the ICU maximum dose
New diagnosis of pulmonary embolism or deep vein thrombosis without anticoagulation for more than 48 hours
Other signs of physiological instability, including temperature <34°C or >41°C, lactate >3.0 mmol/L, creatine kinase >400 U/L, platelet count <20,000/mm³, or suspected muscle inflammation (e.g., rhabdomyolysis, myositis, neuroleptic malignant syndrome, or serotonin syndrome).
This study aims to determine whether NMES, as an early adjunct therapy, can improve recovery and clinical outcomes in critically ill mechanically ventilated patients when combined with conventional physical therapy.
Protocol Amendment and Rationale The study protocol was amended following study initiation due to operational and feasibility constraints identified during the early recruitment phase (from the second enrolled participant onwards), particularly related to limited availability of research personnel required for intervention delivery as originally designed.
Amendments implemented:
- Study duration and intervention schedule The intervention duration was reduced from 20 to 14 days. In addition, the original protocol of two daily sessions during the initial phase was modified to a single daily session throughout the intervention period. Stimulation parameters were also adjusted, including optimization of on/off time and number of contractions, resulting in a shorter and more feasible protocol while maintaining the intended neuromuscular stimulation dose.
- Eligibility criteria modification The exclusion criterion related to baseline mobility was refined. The original criterion excluding patients unable to independently leave the bed was modified to exclude patients who were either unable to leave the bed independently or had pre-existing dependence for mobility prior to hospital admission, in order to improve baseline functional homogeneity and recruitment feasibility.
- Blinding procedures Outcome assessor blinding was removed. Although initially planned, blinding was not feasible due to limited research personnel and logistical constraints associated with intervention delivery.
Rationale:
These amendments were introduced to ensure study feasibility under resource and staffing constraints while maintaining protocol integrity and alignment with the physiological objectives of the intervention.
Importantly, these changes were implemented early in the recruitment process and reflect an adaptation toward a more feasible and clinically applicable protocol.
Impact:
These modifications do not affect the study objectives, primary or secondary outcomes, or participant safety. The intervention remains within established safety parameters for neuromuscular electrical stimulation, and no additional risk to participants has been introduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups in a parallel design: the control group receiving conventional physical therapy, and the intervention group receiving conventional physical therapy plus neuromuscular electrical stimulation. Both groups will be treated simultaneously during the study period.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy | Active comparator | Other: Conventional Physical TherapyParticipants in this group will receive individualized conventional physical therapy, including progressive mobility exercises, in-bed activities (e.g., rolling, sitting at the edge of the bed), standing, transferring to a chair, walking, and respiratory therapy as clinically indicated. Treatments will be adjusted daily based on each patient's physiological status. |
| Conventional Physical Therapy + Neuromuscular Electrical Stimulation | Experimental | Other: Conventional Physical Therapy, Device: Neuromuscular Electrical Stimulation (NMES)Participants in this group will receive the same conventional physical therapy as the control group, plus neuromuscular electrical stimulation (NMES) applied to both lower limbs once or twice daily for 14 consecutive days. NMES will be administered to the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles using specific parameters to produce effective muscle contractions, following a progressive stimulation protocol throughout the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible if they are 18 years or older, are under invasive mechanical ventilation (IMV), and are expected to require IMV for more than 48 hours.
Key exclusion criteria (12 listed)
- Body mass index (BMI) greater than or equal to 35 kg/m²;
- Length of ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation (IMV) before enrollment;
- Known intracranial process (e.g., stroke, intracranial hypertension);
- Neuromuscular disease (e.g., Guillain-Barré syndrome, myasthenia gravis) at ICU admission;
- Inability to speak Portuguese or pre-existing cognitive impairment prior to ICU admission;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physical TherapyIndividualized physical therapy including progressive mobility (e.g., bed exercises, sitting on the edge of the bed, standing, transfers, and ambulation) and respiratory therapy tailored to the patient's clinical condition. Delivered daily by trained professionals. | Other | Conventional Physical Therapy, Conventional Physical Therapy + Neuromuscular Electrical Stimulation |
| Neuromuscular Electrical Stimulation (NMES)NMES will be applied to both lower limbs once or twice daily for 20 consecutive days. Electrodes will be positioned on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. The stimulation protocol includes progressive parameters to induce visible and effective muscle contractions. | Device | Conventional Physical Therapy + Neuromuscular Electrical Stimulation |
Primary outcome
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge
Time frame: Within 24 hours after ICU discharge
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
24 secondary outcomes
Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation
Time frame: within 24 hours after enrollment
Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation
Time frame: within 24 hours after enrollment
Rectus femoris pennation angle measured by ultrasound at sedation awakening
Time frame: Within 24 hours after awakening from sedation in the ICU
Rectus femoris muscle thickness measured by ultrasound at sedation awakening
Time frame: Within 24 hours after awakening from sedation in the ICU
Rectus femoris pennation angle measured by ultrasound at ICU discharge
Time frame: Within 24 hours after ICU discharge
Rectus femoris muscle thickness measured by ultrasound at ICU discharge
Time frame: Within 24 hours after ICU discharge
Rectus femoris pennation angle measured by ultrasound at hospital discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Rectus femoris muscle thickness measured by ultrasound at hospital discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Muscle strength assessed by the Medical Research Council (MRC) sum score at awakening from sedation
Time frame: Within 24 hours after awakening from sedation in the ICU
Muscle strength assessed by the Medical Research Council (MRC) sum score at hospital discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Handgrip strength measured at awakening from sedation in the ICU
Time frame: Within 24 hours after awakening from sedation in the ICU
Handgrip strength measured at ICU discharge
Time frame: Within 24 hours after ICU discharge
Handgrip strength measured at hospital discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Isometric Knee Extension Strength Assessed at Awakening From Sedation in the ICU
Time frame: Within 24 hours after awakening from sedation in the ICU
Isometric Knee Extension Strength Assessed at ICU Discharge
Time frame: Within 24 hours after ICU discharge
Isometric Knee Extension Strength Assessed at Hospital Discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Functional capacity assessed by the Six-Minute Walk Test (6MWT)
Time frame: From 48 hours to 0 hours before hospital discharge
Barthel Index Assessed at Study Enrollment
Time frame: At baseline (study enrollment)
Barthel Index Assessed at Hospital Discharge
Time frame: From 48 hours to 0 hours before hospital discharge
Barthel Index Assessed at 6 Months Post Hospital Discharge
Time frame: 6 months after hospital discharge
Duration of invasive mechanical ventilation (IMV)
Time frame: Within 24 hours after ICU discharge
Ventilator-free days
Time frame: Within 24 hours after ICU discharge
Length of stay in ICU and hospital
Time frame: Within 24 hours after hospital discharge
Mortality
Time frame: From hospital admission until death or up to 180 days (6 months) after hospital discharge, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 31935703Hogrel JY, Benveniste O, Bachasson D. Routine monitoring of isometric knee extension strength in patients with muscle impairments using a new portable device: cross-validation against a standard isokinetic dynamometer. Physiol Meas. 2020 Feb 5;41(1):015003. doi: 10.1088/1361-6579/ab6b49.
- Background: PubMed 24271092Britto RR, Probst VS, de Andrade AF, Samora GA, Hernandes NA, Marinho PE, Karsten M, Pitta F, Parreira VF. Reference equations for the six-minute walk distance based on a Brazilian multicenter study. Braz J Phys Ther. 2013 Nov-Dec;17(6):556-63. doi: 10.1590/S1413-35552012005000122. Epub 2013 Nov 14.
- Background: PubMed 21570036Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
- Background: PubMed 26969168Stefanou C, Karatzanos E, Mitsiou G, Psarra K, Angelopoulos E, Dimopoulos S, Gerovasili V, Boviatsis E, Routsi C, Nanas S. Neuromuscular electrical stimulation acutely mobilizes endothelial progenitor cells in critically ill patients with sepsis. Ann Intensive Care. 2016 Dec;6(1):21. doi: 10.1186/s13613-016-0123-y. Epub 2016 Mar 11.
- Background: PubMed 27732921Silva PE, Babault N, Mazullo JB, de Oliveira TP, Lemos BL, Carvalho VO, Durigan JLQ. Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study. J Crit Care. 2017 Feb;37:141-148. doi: 10.1016/j.jcrc.2016.09.012. Epub 2016 Sep 22.
- Background: PubMed 29995088Sachetti A, Carpes MF, Dias AS, Sbruzzi G. Safety of neuromuscular electrical stimulation among critically ill patients: systematic review. Rev Bras Ter Intensiva. 2018 Apr-Jun;30(2):219-225. doi: 10.5935/0103-507X.20180036.
- Background: PubMed 38633477Padte S, Samala Venkata V, Mehta P, Tawfeeq S, Kashyap R, Surani S. 21st century critical care medicine: An overview. World J Crit Care Med. 2024 Mar 9;13(1):90176. doi: 10.5492/wjccm.v13.i1.90176. eCollection 2024 Mar 9.
- Background: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Background: PubMed 21715139Rodriguez PO, Setten M, Maskin LP, Bonelli I, Vidomlansky SR, Attie S, Frosiani SL, Kozima S, Valentini R. Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation. J Crit Care. 2012 Jun;27(3):319.e1-8. doi: 10.1016/j.jcrc.2011.04.010. Epub 2011 Jun 28.
- Background: PubMed 21811767Nosaka K, Aldayel A, Jubeau M, Chen TC. Muscle damage induced by electrical stimulation. Eur J Appl Physiol. 2011 Oct;111(10):2427-37. doi: 10.1007/s00421-011-2086-x. Epub 2011 Aug 3.
- Background: PubMed 32897665Nakanishi N, Oto J, Tsutsumi R, Yamamoto T, Ueno Y, Nakataki E, Itagaki T, Sakaue H, Nishimura M. Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial. Crit Care Med. 2020 Nov;48(11):e997-e1003. doi: 10.1097/CCM.0000000000004522.
- Background: PubMed 20473619Maffiuletti NA. Physiological and methodological considerations for the use of neuromuscular electrical stimulation. Eur J Appl Physiol. 2010 Sep;110(2):223-34. doi: 10.1007/s00421-010-1502-y. Epub 2010 May 15.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study, including the analyzable dataset, will be shared with qualified researchers for academic purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cassiano TEIXEIRA, PhD principal investigator
Hospital Moinhos de Vento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and Neuromuscular Electrical Stimulation (NMES) in people with Mechanical Ventilation and Critical Illness, run by Hospital Moinhos de Vento at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larissa Carolina Brandão da Cunha, MSc (+5551996285425, larissabran@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge (time frame: Within 24 hours after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188350, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.